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K Number
K002472
Device Name
DELTA 32 AND DELTA 32 TACT
Manufacturer
INSTRUMENTARIUM IMAGING, INC.
Date Cleared
2000-11-29

(110 days)

Product Code
IZH
Regulation Number
892.1710
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.